The present invention relates to an apparatus with unencapsulated reinforcement, and more specifically relates to a therapy delivery element including unencapsulated reinforcement.
Various stimulation leads are used to treat various ailments including overactive bladder symptoms. Over time though, various issues have been noticed with such stimulation leads. For instance, a relatively high number of such stimulation leads that are implanted break during explant, due to, in some instances, the body forming a fibrous capsule around the stimulation lead requiring a force to remove the stimulation lead from the fibrous capsule that is greater than the stimulation lead can withstand before breaking. Breakage of the stimulation lead causes fragments of the stimulation lead to be left behind. In some cases, such fragments can migrate, become painful, and/or cause an infection. In some cases, such fragments have to be surgically removed, causing increased expense, inconvenience, pain, and/or discomfort for the patient.
Another issue is that stimulation leads often have very little ability to stretch. Additionally, over time, body tubing and/or conductor wires of the stimulation lead break down and/or lose strength. Such factors can make the body tubing and/or conductor wires susceptible to breaking under repeated cycles of flexing and/or tensile forces. A fractured conductor can no longer provide the stimulation it was intended to provide. As a result, the stimulation lead either has to be repositioned in the patient or replaced, again causing increased expense, inconvenience, pain, and/or discomfort for the patient.